BUDESONIDE (ENTERIC COATED)

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Overview

What is BUDESONIDE (ENTERIC COATED)?

Budesonide, the active ingredient in budesonide capsules (enteric coated), is a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is CHO and its molecular weight is 430.5. Its structural formula is:

Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 × 103 ionic strength 0.01.

Budesonide capsules (enteric coated) is formulated as hard gelatin capsules filled with enteric-coated granules that dissolve at pH greater than 5.5. Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: acetyltributyl citrate, ethylcellulose, hypromellose, methacrylic acid copolymer (type C powder), polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), talc, and triethyl citrate. The capsule shells have the following inactive ingredients gelatin, D&C red #28, D&C red #33, and titanium dioxide. In addition, the black ink S-1-8114/S-1-8115 contains, black iron oxide, D&C yellow #10 aluminum lake, FD&C blue#1 brilliant blue FCF aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, propylene glycol, and shellac.

What does BUDESONIDE (ENTERIC COATED) look like?

What are the available doses of BUDESONIDE (ENTERIC COATED)?

Capsules: 3 mg ()

What should I talk to my health care provider before I take BUDESONIDE (ENTERIC COATED)?

Pregnancy:

How should I use BUDESONIDE (ENTERIC COATED)?

Budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Pediatric use information is approved for Perrigo Pharma International DAC's ENTOCORT EC (budesonide) capsules. However, due to Perrigo Pharma International DAC's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Take once daily in the morning.

Swallow whole. Do not chew or crush.

Avoid consumption of grapefruit juice for the duration of therapy.

What interacts with BUDESONIDE (ENTERIC COATED)?

Sorry No Records found

What are the warnings of BUDESONIDE (ENTERIC COATED)?

Sorry No Records found

What are the precautions of BUDESONIDE (ENTERIC COATED)?

Sorry No Records found

What are the side effects of BUDESONIDE (ENTERIC COATED)?

Sorry No records found

What should I look out for while using BUDESONIDE (ENTERIC COATED)?

Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred .

What might happen if I take too much BUDESONIDE (ENTERIC COATED)?

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.

If corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism and adrenal axis suppression may occur. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage may be reduced temporarily.

Single oral doses of 200 and 400 mg/kg were lethal in female and male mice, respectively. The signs of acute toxicity were decreased motor activity, piloerection and generalized edema.

How should I store and handle BUDESONIDE (ENTERIC COATED)?

Budesonide Capsules (enteric coated) are size #1 hard gelatin capsules with a pink opaque cap and a white opaque body printed with and '0495' on both cap and body in black ink containing 3 mg of budesonide, USP. Capsules are supplied as follows:55700-590-90Budesonide Capsules (enteric coated) are size #1 hard gelatin capsules with a pink opaque cap and a white opaque body printed with and '0495' on both cap and body in black ink containing 3 mg of budesonide, USP. Capsules are supplied as follows:55700-590-90

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.

Non-Clinical Toxicology

Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred .

When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal axis suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. Since budesonide capsules (enteric coated) contain a corticosteroid, general warnings concerning corticosteroids should be followed.

Pediatric patients with Crohn's disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression than adults with Crohn's disease . Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism and consider reducing the dosage in patients with moderate hepatic impairment (Child-Pugh Class B) .

The following clinically significant adverse reactions are described elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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